Clinical Investigation of A Dual Stream Accelerator Whitening Dentifrice

Tooth whitening is mainly targeted for removal of dental stains, intrinsic and extrinsic. Extrinsic stain can be removed by dental prophylaxis or by regular use of a whitening dentifrice. Removal of intrinsic stain requires chemical agents to whiten the tooth surface structures, the most common of which is hydrogen peroxide. Objective: Human clinical studies assessed the effects of a new whitening technology, with an accelerator system and peroxide, called Simply White^TM dentifrice(SWD). SWD delivers active ingredients via a dual stream system for both extrinsic and intrinsic stain removal. Three proof of concept clinical studies systematically evaluated clinical efficacy of SWD during its technology development. Methods: Healthy human subjects who met the inclusion criteria entered into three respective clinical studies. Study 1 was a 4 week study, which evaluated SWD vs. a regular fluoride dentifrice; Study 2 was a 6 week study, which compared SWD with a non-peroxide commercial whitening dentifrice; Study 3 was an 8 week study which evaluated several SWD variants. All studies were parallel, double blind and randomized. The tooth color change was measured by a classical VITAPAN® shade guide. Study protocols were reviewed and approved to meet appropriate regulatory requirements. Results: Within the 4-week test periods, all SWD formulae tested in three studies improved tooth color between 4.59 and 6.38 VITA shade. SWD whitens teeth significantly better than a regular fluoride dentifrice (6.38 vs. 0.68); SWD was significantly better than a non-peroxide whitening toothpaste (5.52 vs. 4.24 at 4 week or 6.53 vs. 4.61 at 6 weeks. P< 0.01). All SWD variants showed comparable results regardless of the minor changes of excipients. Conclusions: Three respective proof of concept clinical studies demonstrated that SWD provides clinical whitening efficacy. The results suggest that SWD, with a unique accelerator system, delivers both intrinsic and extrinsic whitening benefit.